Description and Brand Names

US Brand Name

Eldepryl

Zelapar

Descriptions

Selegiline is used in combination with levodopa or levodopa and carbidopa combination to treat Parkinson's disease (sometimes called shaking palsy or paralysis agitans). This medicine works to increase and extend the effects of levodopa, and may help to slow the progress of Parkinson's disease.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Capsule

Tablet

Tablet, Disintegrating

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of selegiline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selegiline in the elderly. However, elderly patients are more likely to have unwanted effects (such as hypertension, orthostatic hypotension, unusual drowsiness), which may require caution for patients receiving selegiline.

Pregnancy

Information about this selegiline-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amitriptyline

Amoxapine

Amphetamine

Apraclonidine

Atomoxetine

Benzphetamine

Brimonidine

Bupropion

Carbamazepine

Carbinoxamine

Citalopram

Clomipramine

Cyclobenzaprine

Cyproheptadine

Desipramine

Desvenlafaxine

Dexfenfluramine

Dexmethylphenidate

Dextroamphetamine

Dextromethorphan

Diethylpropion

Doxylamine

Duloxetine

Ephedrine

Escitalopram

Fenfluramine

Fluoxetine

Fluvoxamine

Furazolidone

Guanadrel

Guanethidine

Hydroxytryptophan

Imipramine

Iproniazid

Isocarboxazid

Isometheptene

Levomethadyl

Levomilnacipran

Linezolid

Lisdexamfetamine

Maprotiline

Mazindol

Meperidine

Methadone

Methamphetamine

Methotrimeprazine

Methyldopa

Methylene Blue

Methylphenidate

Milnacipran

Mirtazapine

Moclobemide

Nefopam

Nialamide

Nortriptyline

Opipramol

Paroxetine

Phendimetrazine

Phenelzine

Phenmetrazine

Phentermine

Phenylalanine

Phenylephrine

Phenylpropanolamine

Procarbazine

Propoxyphene

Protriptyline

Pseudoephedrine

Rasagiline

Reserpine

Selegiline

Sertraline

Sibutramine

St John's Wort

Sumatriptan

Tapentadol

Tetrabenazine

Tramadol

Tranylcypromine

Trazodone

Trimipramine

Tryptophan

Venlafaxine

Vilazodone

Vortioxetine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Albuterol

Alizapride

Altretamine

Amineptine

Amisulpride

Amitriptylinoxide

Arformoterol

Avocado

Bambuterol

Bitter Orange

Bromocriptine

Bromperidol

Buspirone

Clenbuterol

Clovoxamine

Colterol

Dibenzepin

Difenoxin

Diphenoxylate

Dolasetron

Domperidone

Dothiepin

Doxepin

Droperidol

Ethchlorvynol

Femoxetine

Fenoterol

Fentanyl

Fluspirilene

Formoterol

Frovatriptan

Granisetron

Guarana

Haloperidol

Hexoprenaline

Hydrocodone

Hydromorphone

Indacaterol

Iobenguane I 123

Isoetharine

Kava

Levalbuterol

Licorice

Lofepramine

Lorcaserin

Ma Huang

Mate

Melitracen

Mephentermine

Metaproterenol

Metaraminol

Metoclopramide

Metopimazine

Morphine

Morphine Sulfate Liposome

Naratriptan

Nefazodone

Nilotinib

Olodaterol

Oxycodone

Palonosetron

Penfluridol

Pentazocine

Pimozide

Pirbuterol

Procaterol

Reboxetine

Reproterol

Ritodrine

Salmeterol

Sulpiride

Sultopride

Terbutaline

Tianeptine

Tiapride

Tretoquinol

Tulobuterol

Tyrosine

Veralipride

Vilanterol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose

Acetohexamide

Benfluorex

Chlorpropamide

Desogestrel

Dienogest

Dopamine

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Ginseng

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Guar Gum

Insulin

Insulin Aspart, Recombinant

Insulin Degludec

Insulin Detemir

Insulin Glargine, Recombinant

Insulin Glulisine

Insulin Human Regular

Insulin Lispro, Recombinant

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Metformin

Miglitol

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Repaglinide

Tolazamide

Tolbutamide

Troglitazone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Dyskinesia (abnormal muscle movements) or

Hypertension (high blood pressure) or

Mental illness (eg, psychosis) or

Postural hypotension (dizziness, lightheadedness, or fainting when getting up from a lying or sitting position)—Use with caution. May make these conditions worse.

Kidney disease, severe—Use is not recommended in patients with this condition.

Liver disease—Use with caution. Higher blood levels of selegiline may result, and cause an increase in side effects.

Phenylketonuria (PKU)—The disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take the capsules or tablets in the morning during breakfast and lunch. You should not use it with dinner because you may have trouble sleeping.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet on the top of your tongue, where it will melt quickly. Do not eat food or drink liquids for 5 minutes before or after taking this medicine. It is best to take this medicine before breakfast.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Parkinson's disease:

For oral dosage forms (capsules or tablets):

Adults—5 milligrams (mg) two times a day, taken at breakfast and lunch. Your doctor may adjust your dose as needed.

Children—Use and dose must be determined by your doctor.

For oral dosage form (oral disintegrating tablets):

Adults—At first, 1.25 milligrams (mg) once a day before breakfast, for at least 6 weeks. After 6 weeks, your doctor may increase your dose to 2.5 mg once a day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Do not take selegiline if you have used meperidine (eg, Demerol®) or an MAO inhibitor (MAOI) (eg, isocarboxazid, phenelzine, tranylcypromine, Marplan®, Nardil®, or Parnate®) within the past 14 days. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not take cyclobenzaprine, dextromethorphan (Robitussin®, Pediacare®), St. John's wort, or pain medicines (eg, methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®) while you are using this medicine. Using these medicines together can cause unwanted effects.

When selegiline is taken at doses of 10 mg or less per day for the treatment of Parkinson's disease, there are no restrictions on food or beverages you eat or drink. However, the chance exists that dangerous reactions, such as sudden high blood pressure, may occur if doses higher than those used for Parkinson's disease are taken with certain foods, beverages, or other medicines. These foods, beverages, and medicines include:

Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses, fava or broad bean pods, yeast or meat extracts, smoked or pickled meat, poultry, or fish, fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat, sauerkraut, or any overripe fruit. If a list of these foods and beverages is not given to you, ask your doctor to provide one.

Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.

Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.

Any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control, “keep awake” products, or products that make you sleepy.

Also, for at least 2 weeks after you stop taking this medicine, these foods, beverages, and other medicines may continue to react with selegiline if it was taken in doses higher than those usually used for Parkinson's disease.

Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor's attention.

This medicine may make you drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Check with your doctor right away if you have pain when swallowing, pain in the mouth, redness, swelling, or sores in your mouth while receiving this medicine.

Selegiline may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased interest in sex while using this medicine.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

unsteadiness, trembling, or other problems with muscle control or coordination

unusual tiredness or weakness

Incidence not known

Agitation

diarrhea

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever

overactive reflexes

poor coordination

restlessness

shivering

sweating

talking or acting with excitement you cannot control

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

chest pain

difficulty opening the mouth or lockjaw

dizziness (severe) or fainting

fast or irregular pulse (continuing)

high fever

high or low blood pressure

severe spasm where the head and heels are bent backward and the body arched forward

troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dry skin

hives, itching, or skin rash

itching, scaling, severe redness, soreness, or swelling of the skin

runny nose

sneezing

stuffy nose

trouble sleeping

Less common

Acid or sour stomach

back pain

belching

bloated or full feeling

body aches or pain

congestion

cough

difficulty having a bowel movement (stool)

difficulty with moving

dryness or soreness of the throat

excess air or gas in the stomach or intestines

heartburn

hoarseness

indigestion

joint pain

leg cramps

muscle aching or cramping

muscle pains or stiffness

passing gas

stomach discomfort, upset, or pain

swollen joints

tender, swollen glands in the neck

tooth problems

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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